A spinal probe incorporating an electromechanical system for detection and prevention of breaches during surgery

Abstract

The present invention is directed to an innovative pedicle probe that uses a force-sensing electromechanical system coupled with haptic and visual feedback. The probe of the present invention reduces the rate of pedicle screw breaches during spinal fusion surgery. The probe provides an effective guidance system to aid surgeons in detecting and preventing cortical bone breaches, thereby minimizing risk of intraoperative injury to the patient. Moreover, the probe invention decreases surgeon reliance on intraoperative radiation, reducing harmful exposure to both patients and surgeons.

1 . A device for spinal surgery comprising:
 a shaft having a first end and a second end and an elongate length therebetween, wherein the first end is configured for probing a vertebra;   a handle having a housing defining an interior space, wherein the second end of the shaft is configured to sit within at least a portion of the interior space;   a rotor configured to couple the shaft to the housing;   a force transducer configured to transmit data regarding forces sensed by the first end of the shaft;   a microprocessor configured to receive input from the force transducer and output data related to the forces sensed by the first end of the shaft; and   a feedback system configured to transmit information to a user.   
     
     
         2 . The device of  claim 1  further comprising a microprocessor loaded with comprising a non-transitory computer readable medium programmed to determine when a cortical wall of the vertebra is breached. 
     
     
         3 . The device of  claim 1  further comprising a microprocessor loaded with comprising a non-transitory computer readable medium programmed to use the penetration depth, force data, and orientation data as inputs to determine position of the device; to compute a likelihood of cortical breach, to activate the feedback system when a pre-programmed threshold is reached. 
     
     
         4 . The device of  claim 3  further comprising the microprocessor being configured for using pre-operative scan data to calibrate position of the probe relative to a patient or vertebra. 
     
     
         5 . The device of  claim 3  further comprising the microprocessor being configured for outputting calculated probe position data overlaying a scan of a vertebra of a patient. 
     
     
         6 . The device of  claim 5  further comprising the microprocessor being configured for outputting the data with a wired transmission over a cable extending from the handle. 
     
     
         7 . The device of  claim 5  further comprising the microprocessor being configured for outputting the data with a wireless transmission from a transmitter positioned within an interior space of the handle to a receiver external to the probe. 
     
     
         8 . The device of  claim 1  wherein the feedback system comprises vibration. 
     
     
         9 . The device of  claim 1  wherein the feedback system comprises a vibrational motor. 
     
     
         10 . The device of  claim 1  wherein the feedback system comprises lights. 
     
     
         11 . The device of  claim 10  wherein the feedback system comprises LEDs. 
     
     
         12 . The device of  claim 1  wherein the feedback system comprises vibration and lights. 
     
     
         13 . The device of  claim 1  wherein the force transducer comprises torque sensing force transducers. 
     
     
         14 . The device of  claim 1  further comprising an internal power source. 
     
     
         15 . The device of  claim 1  further comprising a means of dynamically modulating the signal gain on the output of the force transducers, dependent on the amplitude of the input pressure. 
     
     
         16 . The device of  claim 1  further comprising a means of continuously measuring a depth of penetration of a probe tip into a vertebra during a procedure. 
     
     
         17 . The device of  claim 16  further comprising the means of continuously measuring a depth of penetration relaying the data to the microprocessor as an input. 
     
     
         18 . The device of  claim 16  wherein the measurement is accomplished using electrical components. 
     
     
         19 . The device of  claim 16  wherein the measurement is accomplished using mechanical components. 
     
     
         20 . The device of  claim 1  further comprising an inertial sensor configured to continuously measure the orientation of the probe relative to a fixed plane, which is relayed as an input to the microprocessor.